NCT04577872

Brief Summary

This physiotherapist-guided group training programme should be performed in both the supine and the sitting positions; it is investigated, which is better and more cost-effective in patient motivation.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
Last Updated

November 12, 2020

Status Verified

September 1, 2020

Enrollment Period

2.3 years

First QC Date

September 23, 2020

Last Update Submit

November 9, 2020

Conditions

Keywords

pelvic floor muscle trainingtransverse abdominal muscleultrasound measurementurinary incontinencevaginal surface electromyography

Outcome Measures

Primary Outcomes (1)

  • Investigation of the effects of the pelvic floor muscle training (PFM-T)

    It is measured the change of the pelvic floor muscle with Vaginal surface electromyography (vsEMG).

    28 months

Study Arms (3)

Supine group (n=22)

EXPERIMENTAL

The 22 participants with lower muscle strength (under 60 microvolt) comprised the supine group.

Other: Pelvic floor muscle training

Sitting group (n=19)

EXPERIMENTAL

The 19 participants with higher muscle strength (over 60 microvolt) formed the sitting group.

Other: Pelvic floor muscle training

Control group (n=14)

NO INTERVENTION

The control group comprised 7 individuals with lower muscle strength (under 60 microvolt) and 7 with higher muscle strength (over 60 microvolt)

Interventions

The treatment for the sitting group comprised 8 sessions, with a 1-hour combined pelvic floor muscle training (cPFM-T) session each week in a group and 15 minutes of individual home training, six times a week for a total of 8 weeks of treatment. All training sessions comprised warming-up, gradual muscle strengthening and relaxation exercises. In the study, before and after the training programme, we used a self-administered questionnaire.We measured changes in pelvic floor muscle activity with a vaginal surface electromyographic instrument. We performed the transversus abdominis measurements at the same time as the vaginal measurements and pelvic floor muscle tasks.

Sitting group (n=19)Supine group (n=22)

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsnulliparous women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • We included in the study groups women participants willing to participate in the study and able to contract the pelvic floor and transversus abdominis muscles correctly. Participants were required to maintain their everyday activities (attending lessons, sport activities, and so on).

You may not qualify if:

  • known neurological or rheumatological diseases and previous vaginal or abdominal surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Madill SJ, McLean L. Quantification of abdominal and pelvic floor muscle synergies in response to voluntary pelvic floor muscle contractions. J Electromyogr Kinesiol. 2008 Dec;18(6):955-64. doi: 10.1016/j.jelekin.2007.05.001. Epub 2007 Jul 23.

    PMID: 17646112BACKGROUND
  • Chmielewska D, Stania M, Sobota G, Kwasna K, Blaszczak E, Taradaj J, Juras G. Impact of different body positions on bioelectrical activity of the pelvic floor muscles in nulliparous continent women. Biomed Res Int. 2015;2015:905897. doi: 10.1155/2015/905897. Epub 2015 Feb 22.

    PMID: 25793212BACKGROUND
  • Haslam J. The prevalence of stress urinary incontinence in women. Nurs Times. 2004 May 18;100(20):71-3. No abstract available.

  • KEGEL AH. Progressive resistance exercise in the functional restoration of the perineal muscles. Am J Obstet Gynecol. 1948 Aug;56(2):238-48. doi: 10.1016/0002-9378(48)90266-x. No abstract available.

  • Dumoulin C, Cacciari LP, Hay-Smith EJC. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2018 Oct 4;10(10):CD005654. doi: 10.1002/14651858.CD005654.pub4.

  • Capson AC, Nashed J, Mclean L. The role of lumbopelvic posture in pelvic floor muscle activation in continent women. J Electromyogr Kinesiol. 2011 Feb;21(1):166-77. doi: 10.1016/j.jelekin.2010.07.017. Epub 2010 Sep 15.

  • Sapsford RR, Richardson CA, Stanton WR. Sitting posture affects pelvic floor muscle activity in parous women: an observational study. Aust J Physiother. 2006;52(3):219-22. doi: 10.1016/s0004-9514(06)70031-9.

Related Links

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Edit Nagy, Habil. PhD

    University of Szeged, Faculty of Health Sciences and Social Studies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2020

First Posted

October 8, 2020

Study Start

January 1, 2016

Primary Completion

April 30, 2018

Study Completion

January 31, 2019

Last Updated

November 12, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share